Text of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2012

This bill was introduced in a previous session of Congress and was passed by the House on December 19, 2012 but was never passed by the Senate. The text of the bill below is as of Dec 19, 2012 (Received by the Senate).

To reauthorize certain programs under the
Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with
respect to public health security and all-hazards preparedness and response,
and for other purposes.

1.

Short title; table of
contents

(a)

Short
title

This Act may be cited as the Pandemic and All-Hazards Preparedness Reauthorization Act
of 2012.

(b)

Table of
contents

The table of contents of this Act is as follows:

Sec. 1. Short title; table of contents.

Title I—Strengthening national preparedness and response for
public health emergencies

Sec. 101. National Health Security Strategy.

Sec. 102. Assistant Secretary for Preparedness and
Response.

Sec. 103. National Advisory Committee on Children and
Disasters.

Sec. 104. Modernization of the National Disaster Medical
System.

Sec. 105. Continuing the role of the Department of Veterans
Affairs.

Title II—Optimizing State and local all-hazards preparedness and
response

Sec. 201. Temporary redeployment of federally funded personnel
during a public health emergency.

Sec. 202. Improving State and local public health
security.

Sec. 203. Hospital preparedness and medical surge
capacity.

Sec. 204. Enhancing situational awareness and
biosurveillance.

Sec. 205. Eliminating duplicative Project Bioshield
reports.

Title III—Enhancing Medical Countermeasure Review

Sec. 301. Special protocol assessment.

Sec. 302. Authorization for medical products for use in
emergencies.

Sec. 303. Definitions.

Sec. 304. Enhancing medical countermeasure
activities.

Sec. 305. Regulatory management plans.

Sec. 306. Report.

Sec. 307. Pediatric medical countermeasures.

Title IV—Accelerating medical countermeasure advanced research
and development

Sec. 401. BioShield.

Sec. 402. Biomedical Advanced Research and Development
Authority.

Sec. 403. Strategic National Stockpile.

Sec. 404. National Biodefense Science Board.

I

Strengthening national preparedness and
response for public health emergencies

101.

National Health Security Strategy

(a)

In general

Section 2802 of the Public Health Service
Act (42 U.S.C.
300hh–1) is amended—

(1)

in subsection (a)(1), by striking
2009 and inserting 2014; and

(2)

in subsection (b)—

(A)

in paragraph
(1)(A), by inserting , including drills and exercises to ensure medical
surge capacity for events without notice after
exercises; and

(B)

in paragraph (3)—

(i)

in the matter preceding subparagraph
(A)—

(I)

by striking facilities), and trauma
care and inserting and ambulatory care facilities and which may
include dental health facilities), and trauma care, critical care,;
and

(II)

by inserting (including related
availability, accessibility, and coordination) after public
health emergencies;

in subparagraph (E), as redesignated by
clause (iv), by inserting (which may include such dental health
assets) after medical assets; and

(vii)

by adding at the end the following:

(G)

Optimizing a coordinated and flexible
approach to the medical surge capacity of hospitals, other health care
facilities, critical care, and trauma care (which may include trauma centers)
and emergency medical
systems.

;

(C)

in paragraph (4)—

(i)

in subparagraph (A), by inserting ,
including the unique needs and considerations of individuals with
disabilities, after medical needs of at-risk
individuals; and

(ii)

in subparagraph (B), by inserting
the before purpose of this section; and

For purposes of this paragraph, the term
countermeasures has the same meaning as the terms qualified
countermeasures under section 319F–1, qualified pandemic and
epidemic products under section 319F–3, and security
countermeasures under section 319F–2.

(8)

Medical and public health community
resiliency

Strengthening the
ability of States, local communities, and tribal communities to prepare for,
respond to, and be resilient in the event of public health emergencies, whether
naturally occurring, unintentional, or deliberate by—

(A)

optimizing alignment and integration of
medical and public health preparedness and response planning and capabilities
with and into routine daily activities; and

(B)

promoting familiarity with local medical
and public health
systems.

.

(b)

At-Risk individuals

Section 2814 of the Public Health Service
Act (42 U.S.C.
300hh–16) is amended—

(1)

by striking paragraphs (5), (7), and
(8);

(2)

in paragraph (4),
by striking 2811(b)(3)(B) and inserting
2802(b)(4)(B);

(3)

by redesignating paragraphs (1) through (4)
as paragraphs (2) through (5), respectively;

(4)

by inserting before paragraph (2) (as so
redesignated), the following:

(1)

monitor emerging issues and concerns as
they relate to medical and public health preparedness and response for at-risk
individuals in the event of a public health emergency declared by the Secretary
under section
319;

;

(5)

by amending paragraph (2) (as so
redesignated) to read as follows:

(2)

oversee the implementation of the
preparedness goals described in section 2802(b) with respect to the public
health and medical needs of at-risk individuals in the event of a public health
emergency, as described in section
2802(b)(4);

;

(6)

by inserting after paragraph (6), the
following:

(7)

disseminate and, as appropriate, update
novel and best practices of outreach to and care of at-risk individuals before,
during, and following public health emergencies in as timely a manner as is
practicable, including from the time a public health threat is identified;
and

(8)

ensure that public health and medical
information distributed by the Department of Health and Human Services during a
public health emergency is delivered in a manner that takes into account the
range of communication needs of the intended recipients, including at-risk
individuals.

.

102.

Assistant Secretary for Preparedness and
Response

(a)

In general

Section 2811 of the Public Health Service
Act (42 U.S.C.
300hh–10) is amended—

Provide integrated
policy coordination and strategic direction with respect to all matters related
to Federal public health and medical preparedness and execution and deployment
of the Federal response for public health emergencies and incidents covered by
the National Response Plan developed pursuant to section 504(6) of the Homeland
Security Act of 2002, or any successor plan, before, during, and following
public health emergencies.

(E)

Identification
of inefficiencies

Identify and minimize gaps, duplication, and
other inefficiencies in medical and public health preparedness and response
activities and the actions necessary to overcome these obstacles.

(F)

Coordination of
grants and agreements

Align
and coordinate medical and public health grants and cooperative agreements as
applicable to preparedness and response activities authorized under this Act,
to the extent possible, including program requirements, timelines, and
measurable goals, and in consultation with the Secretary of Homeland Security,
to—

(i)

optimize and streamline medical and public
health preparedness and response capabilities and the ability of local
communities to respond to public health emergencies; and

(ii)

gather and disseminate best practices among
grant and cooperative agreement recipients, as appropriate.

(G)

Drill and
operational exercises

Carry
out drills and operational exercises, in consultation with the Department of
Homeland Security, the Department of Defense, the Department of Veterans
Affairs, and other applicable Federal departments and agencies, as necessary
and appropriate, to identify, inform, and address gaps in and policies related
to all-hazards medical and public health preparedness and response, including
exercises based on—

(i)

identified threats for which
countermeasures are available and for which no countermeasures are available;
and

(ii)

unknown threats for which no
countermeasures are available.

(H)

National security priority

On a periodic basis consult with, as
applicable and appropriate, the Assistant to the President for National
Security Affairs, to provide an update on, and discuss, medical and public
health preparedness and response activities pursuant to this Act and the
Federal Food, Drug, and Cosmetic Act, including progress on the development,
approval, clearance, and licensure of medical
countermeasures.

;
and

(C)

by adding at the
end the following:

(7)

Countermeasures budget plan

Develop, and update on an annual basis, a
coordinated 5-year budget plan based on the medical countermeasure priorities
described in subsection (d). Each such plan shall—

(A)

include consideration of the entire medical
countermeasures enterprise, including—

(i)

basic research and advanced research and
development;

(ii)

approval, clearance, licensure, and
authorized uses of products; and

(iii)

procurement, stockpiling, maintenance, and
replenishment of all products in the Strategic National Stockpile;

(B)

inform prioritization of resources and
include measurable outputs and outcomes to allow for the tracking of the
progress made toward identified priorities;

(C)

identify medical countermeasure life-cycle
costs to inform planning, budgeting, and anticipated needs within the continuum
of the medical countermeasure enterprise consistent with section 319F–2;
and

(D)

be made available to the appropriate
committees of Congress upon
request.

;

(2)

by striking subsection (c) and inserting
the following:

(c)

Functions

The Assistant Secretary for Preparedness
and Response shall—

(1)

have lead responsibility within the
Department of Health and Human Services for emergency preparedness and response
policy coordination and strategic direction;

(2)

have authority over and responsibility
for—

(A)

the National Disaster Medical System
pursuant to section 2812;

(B)

the Hospital Preparedness Cooperative
Agreement Program pursuant to section 319C–2;

(C)

the Biomedical
Advanced Research and Development Authority pursuant to section 319L;

(D)

the Medical Reserve Corps pursuant to
section 2813;

(E)

the Emergency System for Advance
Registration of Volunteer Health Professionals pursuant to section 319I;
and

(F)

administering grants and related
authorities related to trauma care under parts A through C of title XII, such
authority to be transferred by the Secretary from the Administrator of the
Health Resources and Services Administration to such Assistant
Secretary;

(3)

exercise the responsibilities and
authorities of the Secretary with respect to the coordination of—

(A)

the Public Health Emergency Preparedness
Cooperative Agreement Program pursuant to section 319C–1;

Not later than 180 days after the date of
enactment of this subsection, and every year thereafter, the Assistant
Secretary for Preparedness and Response shall develop and submit to the
appropriate committees of Congress a coordinated strategy and accompanying
implementation plan for medical countermeasures to address chemical,
biological, radiological, and nuclear threats. In developing such a plan, the
Assistant Secretary for Preparedness and Response shall consult with the
Director of the Biomedical Advanced Research and Development Authority, the
Director of the National Institutes of Health, the Director of the Centers for
Disease Control and Prevention, and the Commissioner of Food and Drugs. Such
strategy and plan shall be known as the Public Health Emergency Medical
Countermeasures Enterprise Strategy and Implementation Plan.

(2)

Requirements

The plan under paragraph (1) shall—

(A)

describe the chemical, biological,
radiological, and nuclear agent or agents that may present a threat to the
Nation and the corresponding efforts to develop qualified countermeasures (as
defined in section 319F–1), security countermeasures (as defined in section
319F–2), or qualified pandemic or epidemic products (as defined in section
319F–3) for each threat;

(B)

evaluate the
progress of all activities with respect to such countermeasures or products,
including research, advanced research, development, procurement, stockpiling,
deployment, distribution, and utilization;

(C)

identify and
prioritize near-, mid-, and long-term needs with respect to such
countermeasures or products to address a chemical, biological, radiological,
and nuclear threat or threats;

(D)

identify, with respect to each category of
threat, a summary of all awards and contracts, including advanced research and
development and procurement, that includes—

(i)

the time elapsed from the issuance of the
initial solicitation or request for a proposal to the adjudication (such as the
award, denial of award, or solicitation termination); and

(ii)

an identification of projected timelines,
anticipated funding allocations, benchmarks, and milestones for each medical
countermeasure priority under subparagraph (C), including projected needs with
regard to replenishment of the Strategic National Stockpile;

(E)

be informed by the recommendations of the
National Biodefense Science Board pursuant to section 319M;

report on the
amount of funds available for procurement in the special reserve fund as
defined in section 319F–2(h) and the impact this funding will have on meeting
the requirements under section 319F–2;

identify the progress made in meeting the
medical countermeasure priorities for at-risk individuals (as defined in
2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to
the projected needs for related stockpiling and replenishment of the Strategic
National Stockpile, including by addressing the needs of pediatric populations
with respect to such countermeasures and products in the Strategic National
Stockpile, including—

(i)

a
list of such countermeasures and products necessary to address the needs of
pediatric populations;

(ii)

a
description of measures taken to coordinate with the Office of Pediatric
Therapeutics of the Food and Drug Administration to maximize the labeling,
dosages, and formulations of such countermeasures and products for pediatric
populations;

(iii)

a description of
existing gaps in the Strategic National Stockpile and the development of such
countermeasures and products to address the needs of pediatric populations;
and

(iv)

an evaluation of
the progress made in addressing priorities identified pursuant to subparagraph
(C);

(J)

identify the use of authority and
activities undertaken pursuant to sections 319F–1(b)(1), 319F–1(b)(2),
319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F–2(c)(7)(C)(iii), 319F–2
(c)(7)(C)(iv), and 319F–2(c)(7)(C)(v) of this Act, and subsections (a)(1),
(b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act, by
summarizing—

(i)

the particular
actions that were taken under the authorities specified, including, as
applicable, the identification of the threat agent, emergency, or the
biomedical countermeasure with respect to which the authority was used;

(ii)

the reasons
underlying the decision to use such authorities, including, as applicable, the
options that were considered and rejected with respect to the use of such
authorities;

(iii)

the number of,
nature of, and other information concerning the persons and entities that
received a grant, cooperative agreement, or contract pursuant to the use of
such authorities, and the persons and entities that were considered and
rejected for such a grant, cooperative agreement, or contract, except that the
report need not disclose the identity of any such person or entity;

(iv)

whether, with
respect to each procurement that is approved by the President under section
319F–2(c)(6), a contract was entered into within one year after such approval
by the President; and

(v)

with respect to
section 319F–1(d), for the one-year period for which the report is submitted,
the number of persons who were paid amounts totaling $100,000 or greater and
the number of persons who were paid amounts totaling at least $50,000 but less
than $100,000; and

(K)

be made publicly available.

(3)

GAO report

(A)

In general

Not later than 1 year after the date of the
submission to the Congress of the first Public Health Emergency Medical
Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller
General of the United States shall conduct an independent evaluation, and
submit to the appropriate committees of Congress a report, concerning such
Strategy and Implementation Plan.

(B)

Content

The report described in subparagraph (A)
shall review and assess—

(i)

the near-term, mid-term, and long-term
medical countermeasure needs and identified priorities of the Federal
Government pursuant to paragraph (2)(C);

(ii)

the activities of the Department of Health
and Human Services with respect to advanced research and development pursuant
to section 319L; and

(iii)

the progress made toward meeting the
timelines, allocations, benchmarks, and milestones identified in the Public
Health Emergency Medical Countermeasures Enterprise Strategy and Implementation
Plan under this subsection.

(e)

Protection of national
security

In carrying out
subsections (b)(7) and (d), the Secretary shall ensure that information and
items that could compromise national security, contain confidential commercial
information, or contain proprietary information are not
disclosed.

.

(b)

Interagency
coordination plan

In the first Public Health Emergency
Countermeasures Enterprise Strategy and Implementation Plan submitted under
subsection (d) of section 2811 of the Public Health Service Act (42 U.S.C.
300hh–10) (as added by subsection (a)(3)), the Secretary of
Health and Human Services, in consultation with the Secretary of Defense, shall
include a description of the manner in which the Department of Health and Human
Services is coordinating with the Department of Defense regarding
countermeasure activities to address chemical, biological, radiological, and
nuclear threats. Such report shall include information with respect to—

(1)

the research,
advanced research, development, procurement, stockpiling, and distribution of
countermeasures to meet identified needs; and

(2)

the coordination
of efforts between the Department of Health and Human Services and the
Department of Defense to address countermeasure needs for various segments of
the population.

103.

National Advisory Committee on Children and
Disasters

Subtitle B of title
XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.) is
amended by inserting after section 2811 the following:

2811A.

National Advisory Committee on Children and
Disasters

(a)

Establishment

The Secretary, in consultation with the
Secretary of Homeland Security, shall establish an advisory committee to be
known as the National Advisory Committee on Children and
Disasters (referred to in this section as the Advisory
Committee).

(b)

Duties

The Advisory Committee shall—

(1)

provide advice and consultation with
respect to the activities carried out pursuant to section 2814, as applicable
and appropriate;

(2)

evaluate and provide input with respect to
the medical and public health needs of children as they relate to preparation
for, response to, and recovery from all-hazards emergencies; and

(3)

provide advice and consultation with
respect to State emergency preparedness and response activities and children,
including related drills and exercises pursuant to the preparedness goals under
section 2802(b).

(c)

Additional duties

The Advisory Committee may provide advice
and recommendations to the Secretary with respect to children and the medical
and public health grants and cooperative agreements as applicable to
preparedness and response activities authorized under this title and title
III.

(d)

Membership

(1)

In general

The Secretary, in consultation with such
other Secretaries as may be appropriate, shall appoint not to exceed 15 members
to the Advisory Committee. In appointing such members, the Secretary shall
ensure that the total membership of the Advisory Committee is an odd
number.

(2)

Required members

The Secretary, in consultation with such
other Secretaries as may be appropriate, may appoint to the Advisory Committee
under paragraph (1) such individuals as may be appropriate to perform the
duties described in subsections (b) and (c), which may include—

(A)

the Assistant Secretary for Preparedness
and Response;

(B)

the Director of the Biomedical Advanced
Research and Development Authority;

(C)

the Director of the Centers for Disease
Control and Prevention;

(D)

the Commissioner of Food and Drugs;

(E)

the Director of the National Institutes of
Health;

(F)

the Assistant Secretary of the
Administration for Children and Families;

at least two representatives from State,
local, territorial, or tribal agencies with expertise in pediatric disaster
planning, preparedness, response, or recovery; and

(J)

representatives from such Federal agencies
(such as the Department of Education and the Department of Homeland Security)
as determined necessary to fulfill the duties of the Advisory Committee, as
established under subsections (b) and (c).

(e)

Meetings

The Advisory Committee shall meet not less
than biannually.

(f)

Sunset

The Advisory Committee shall terminate on
the date that is 5 years after the date of enactment of the
Pandemic and All-Hazards Preparedness
Reauthorization Act of
2012.

.

104.

Modernization of the National Disaster
Medical System

Section 2812 of
the Public Health Service Act (42 U.S.C. 300hh–11) is
amended—

(1)

in subsection (a)(3)—

(A)

in subparagraph (A), in clause (i) by
inserting , including at-risk individuals as applicable after
victims of a public health emergency;

(B)

by redesignating subparagraph (C) as
subparagraph (E); and

(C)

by inserting after subparagraph (B), the
following:

(C)

Considerations for at-risk
populations

The Secretary
shall take steps to ensure that an appropriate specialized and focused range of
public health and medical capabilities are represented in the National Disaster
Medical System, which take into account the needs of at-risk individuals, in
the event of a public health
emergency.

.

(D)

Administration

The Secretary may determine and pay claims
for reimbursement for services under subparagraph (A) directly or through
contracts that provide for payment in advance or by way of
reimbursement.

;
and

(2)

in subsection (g), by striking such
sums as may be necessary for each of the fiscal years 2007 through 2011
and inserting $52,700,000 for each of fiscal years 2013 through
2017.

105.

Continuing the role of the Department of
Veterans Affairs

Section 8117(g) of
title 38, United States Code, is amended by striking such sums as may be
necessary to carry out this section for each of fiscal years 2007 through
2011 and inserting $155,300,000 for each of fiscal years 2013
through 2017 to carry out this section.

II

Optimizing State
and local all-hazards preparedness and response

201.

Temporary
redeployment of federally funded personnel during a public health
emergency

Section 319 of the
Public Health Service Act (42 U.S.C. 247d) is amended by
adding at the end the following:

(e)

Temporary
redeployment of federally funded personnel during a public health
emergency

(1)

Emergency
redeployment of federally funded personnel

Notwithstanding any other provision of law,
and subject to paragraph (2), upon request by the Governor of a State or the
chief of a tribe or such Governor or chief’s designee, the Secretary may
authorize the requesting State or tribe to temporarily redeploy, for purposes
of immediately addressing a public health emergency in the State or tribe,
non-Federal personnel funded in whole or in part through, as appropriate,
programs under this Act.

(2)

Activation of
emergency redeployment

(A)

Public health
emergency

The Secretary may
authorize a temporary redeployment of personnel under paragraph (1) only during
the period of a public health emergency determined pursuant to subsection
(a).

(B)

Contents of
request

To seek authority for
a temporary redeployment of personnel under paragraph (1), the Governor of a
State or the chief of a tribe shall submit to the Secretary a request for such
authority and shall include in the request each of the following:

(i)

An assurance that the public health
emergency in the geographic area of the requesting State or tribe cannot be
adequately and appropriately addressed by the public health workforce otherwise
available.

(ii)

An assurance that the public health
emergency would be addressed more efficiently and effectively through the
requested temporary redeployment of personnel.

(iii)

An assurance
that the requested temporary redeployment of personnel is consistent with the
any applicable All-Hazards Public Health Emergency Preparedness and Response
Plan under section 319C–1.

(iv)

An identification
of—

(I)

each Federal
program from which personnel would be temporarily redeployed pursuant to the
requested authority; and

(II)

the number of
personnel who would be so redeployed from each such program.

(v)

Such other
information and assurances as the Secretary may require.

(C)

Consideration

In
reviewing a request for temporary redeployment under paragraph (1) of personnel
funded through a Federal program, the Secretary shall consider the degree to
which the program would be adversely affected by the redeployment.

(D)

Termination and
extension

(i)

Termination

A State or tribe’s authority for a
temporary redeployment of personnel under paragraph (1) shall terminate upon
the earlier of the following:

(I)

The Secretary’s
determination that the public health emergency no longer exists.

(II)

Subject to clause
(ii), the expiration of the 30-day period following the date on which the
Secretary approved the State or tribe’s request for such authority.

(ii)

Extension
authority

The Secretary may extend the authority to authorize a
temporary redeployment of personnel under paragraph (1) beyond the date
otherwise applicable under clause (i)(II) if the public health emergency still
exists as of such date, but only if—

(I)

the State or tribe
that submitted the initial request for authority for a temporary redeployment
of personnel submits a request for an extension of such authority; and

(II)

the request for
an extension contains the same type of information and assurances necessary for
the approval of an initial request for such authority.

(3)

Notice to
personnel of possibility of redeployment

The Secretary shall
ensure that, if a State or tribe receives Federal funds for personnel who are
subject to the Secretary’s redeployment authority under this subsection, the
State or tribe gives notice to such personnel of the possibility of
redeployment—

(A)

at the time of
hiring; or

(B)

in the case of
personnel hired before the date of the enactment of this subsection, as soon as
practicable.

(4)

Notice to
Congress

The Secretary shall give notice to the Congress in
conjunction with the approval under this subsection of—

(A)

any initial
request for authority for a temporary redeployment of personnel; and

(B)

any request for an
extension of such authority.

(5)

Guidance

The
Secretary shall—

(A)

not later than 6
months after the enactment of this subsection, issue proposed guidance on the
temporary redeployment of personnel under this subsection; and

(B)

after providing notice and a 60-day period
for public comment, finalize such guidance.

(6)

Report to
Congress

Not later than 4
years after the date of enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act
of 2012, the Comptroller General of the United States shall
conduct an independent evaluation, and submit to the appropriate committees of
the Congress a report, on the Secretary’s authority under this subsection,
including—

(A)

a description of
how, and under what circumstances, such authority has been used by States and
tribes;

(B)

an analysis of how
such authority has assisted States and tribes in responding to public health
emergencies;

(C)

an evaluation of
how such authority has improved operational efficiencies in responding to
public health emergencies;

(D)

an analysis of the
extent to which, if any, Federal programs from which personnel have been
temporarily redeployed pursuant to such authority have been adversely affected
by the redeployment; and

(E)

recommendations on
how such authority could be improved to further assist in responding to public
health emergencies.

(7)

Definition

In
this subsection, the term State includes, in addition to the
entities listed in the definition of such term in section 2, the Freely
Associated States.

(8)

Sunset

The
authority under this subsection shall terminate on the date that is 5 years
after the date of enactment of the Pandemic
and All-Hazards Preparedness Reauthorization Act of 2012.

.

202.

Improving State
and local public health security

(a)

Cooperative
agreements

Section 319C–1 of
the Public Health Service Act (42 U.S.C. 247d–3a) is
amended—

(1)

in subsection (b)(1)(C), by striking
consortium of entities described in subparagraph (A) and
inserting consortium of States;

(2)

in subsection
(b)(2)—

(A)

in subparagraph (A)—

(i)

by striking clauses (i) and (ii) and
inserting the following:

(i)

a description of the activities such entity
will carry out under the agreement to meet the goals identified under section
2802, including with respect to chemical, biological, radiological, or nuclear
threats, whether naturally occurring, unintentional, or deliberate;

(ii)

a description of the activities such entity
will carry out with respect to pandemic influenza, as a component of the
activities carried out under clause (i), and consistent with the requirements
of paragraphs (2) and (5) of subsection
(g);

;

(ii)

in clause (iv), by striking
and at the end; and

(iii)

by adding at the end the following:

(vi)

a description of how, as appropriate, the
entity may partner with relevant public and private stakeholders in public
health emergency preparedness and response;

(vii)

a description of how the entity, as
applicable and appropriate, will coordinate with State emergency preparedness
and response plans in public health emergency preparedness, including State
educational agencies (as defined in section 9101(41) of the Elementary and
Secondary Education Act of 1965) and State child care lead agencies (designated
under section 658D of the Child Care and Development Block Grant Act of
1990);

(viii)

in the case of entities that operate on the
United States-Mexico border or the United States-Canada border, a description
of the activities such entity will carry out under the agreement that are
specific to the border area including disease detection, identification,
investigation, and preparedness and response activities related to emerging
diseases and infectious disease outbreaks whether naturally occurring or due to
bioterrorism, consistent with the requirements of this section; and

(ix)

a description of any activities that such
entity will use to analyze real-time clinical specimens for pathogens of public
health or bioterrorism significance, including any utilization of poison
control centers;

;
and

(B)

in subparagraph (C), by inserting ,
including addressing the needs of at-risk individuals, after
capabilities of such entity;

(3)

in subsection
(f)—

(A)

in paragraph (2),
by adding and at the end;

(B)

in paragraph (3),
by striking ; and and inserting a period; and

(C)

by striking
paragraph (4);

(4)

in subsection (g)—

(A)

in paragraph (1), by striking subparagraph
(A) and inserting the following:

(A)

include outcome goals representing
operational achievements of the National Preparedness Goals developed under
section 2802(b) with respect to all-hazards, including chemical, biological,
radiological, or nuclear threats; and

;
and

(B)

in paragraph (2)(A), by adding at the end
the following: The Secretary shall periodically update, as necessary and
appropriate, such pandemic influenza plan criteria and shall require the
integration of such criteria into the benchmarks and standards described in
paragraph (1).;

(5)

by striking
subsection (h);

(6)

in subsection
(i)—

(A)

in paragraph
(1)—

(i)

in
subparagraph (A)—

(I)

by striking $824,000,000 for fiscal
year 2007, of which $35,000,000 shall be used to carry out subsection
(h), and inserting $641,900,000 for fiscal year 2013;
and

(II)

by striking such sums as may be
necessary for each of fiscal years 2008 through 2011 and inserting
$641,900,000 for each of fiscal years 2014 through 2017;

(ii)

by striking
subparagraph (B);

(iii)

by redesignating
subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively;
and

(iv)

in
subparagraph (C), as so redesignated, by striking subparagraph
(C) and inserting subparagraph (B);

(B)

in subparagraphs
(C) and (D) of paragraph (3), by striking (1)(A)(i)(I) each
place it appears and inserting (1)(A);

(C)

in paragraph
(4)(B), by striking subsection (c) and inserting
subsection (b); and

(D)

by adding at the end the following:

(7)

Availability of cooperative agreement
funds

(A)

In general

Amounts provided to an eligible entity
under a cooperative agreement under subsection (a) for a fiscal year and
remaining unobligated at the end of such year shall remain available to such
entity for the next fiscal year for the purposes for which such funds were
provided.

(B)

Funds contingent on achieving
benchmarks

The continued
availability of funds under subparagraph (A) with respect to an entity shall be
contingent upon such entity achieving the benchmarks and submitting the
pandemic influenza plan as described in subsection
(g).

;
and

(7)

in subsection (j),
by striking paragraph (3).

(b)

Vaccine tracking and
distribution

Section 319A(e)
of the Public Health Service Act (42 U.S.C. 247d–1(e)) is amended
by striking such sums for each of fiscal years 2007 through 2011
and inserting $30,800,000 for each of fiscal years 2013 through
2017.

203.

Hospital preparedness and medical surge
capacity

(a)

All-Hazards public health and medical
response curricula and training

Section 319F(a)(5)(B) of the Public Health
Service Act (42
U.S.C. 247d–6(a)(5)(B)) is amended by striking public
health or medical and inserting public health, medical, or
dental.

(b)

Encouraging health professional
volunteers

(1)

Emergency system for advance registration
of volunteer health professionals

Section 319I(k) of the Public Health
Service Act (42 U.S.C. 247d–7b(k)) is amended by striking $2,000,000 for
fiscal year 2002, and such sums as may be necessary for each of the fiscal
years 2003 through 2011 and inserting $5,000,000 for each of
fiscal years 2013 through 2017.

(2)

Volunteers

Section 2813 of the Public Health Service
Act (42 U.S.C.
300hh–15) is amended—

(A)

in subsection (d)(2), by adding at the end
the following: Such training exercises shall, as appropriate and
applicable, incorporate the needs of at-risk individuals in the event of a
public health emergency.; and

(B)

in subsection (i), by striking
$22,000,000 for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2011 and inserting $11,200,000
for each of fiscal years 2013 through 2017.

(c)

Partnerships for State and regional
preparedness To improve surge capacity

Section 319C–2 of the Public Health Service
Act (42 U.S.C.
247d–3b) is amended—

(1)

in subsection (a),
by inserting , including capacity and preparedness to address the needs
of pediatric and other at-risk populations before the period at the
end;

An award under subsection (a) shall be
expended for activities to achieve the preparedness goals described under
paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to
all-hazards, including chemical, biological, radiological, or nuclear
threats.

;

(4)

by striking subsection (g) and inserting
the following:

(g)

Coordination

(1)

Local response capabilities

An eligible entity shall, to the extent
practicable, ensure that activities carried out under an award under subsection
(a) are coordinated with activities of relevant local Metropolitan Medical
Response Systems, local Medical Reserve Corps, the local Cities Readiness
Initiative, and local emergency plans.

(2)

National collaboration

Partnerships consisting of one or more
eligible entities under this section may, to the extent practicable,
collaborate with other partnerships consisting of one or more eligible entities
under this section for purposes of national coordination and collaboration with
respect to activities to achieve the preparedness goals described under
paragraphs (1), (3), (4), (5), and (6) of section
2802(b).

;

(5)

in subsection
(i)—

(A)

by striking
The requirements of and inserting the following:

(1)

In
general

The requirements
of

; and

(B)

by adding at the
end the following:

(2)

Meeting goals of
National Health Security Strategy

The Secretary shall implement objective,
evidence-based metrics to ensure that entities receiving awards under this
section are meeting, to the extent practicable, the applicable goals of the
National Health Security Strategy under section
2802.

;
and

(6)

in subsection
(j)—

(A)

by amending
paragraph (1) to read as follows:

(1)

In
general

For purposes of
carrying out this section, there is authorized to be appropriated $374,700,000
for each of fiscal years 2013 through
2017.

; and

(B)

by adding at the end the following:

(4)

Availability of cooperative agreement
funds

(A)

In general

Amounts provided to an eligible entity
under a cooperative agreement under subsection (a) for a fiscal year and
remaining unobligated at the end of such year shall remain available to such
entity for the next fiscal year for the purposes for which such funds were
provided.

(B)

Funds contingent on achieving
benchmarks

The continued
availability of funds under subparagraph (A) with respect to an entity shall be
contingent upon such entity achieving the benchmarks and submitting the
pandemic influenza plan as required under subsection
(i).

.

204.

Enhancing situational awareness and
biosurveillance

Section 319D
of the Public Health Service Act (42 U.S.C. 247d–4) is
amended—

(1)

in subsection (b)—

(A)

in paragraph (1)(B), by inserting
poison control centers, after hospitals,;

(B)

in paragraph (2), by inserting before the
period at the end the following: , allowing for coordination to maximize
all-hazards medical and public health preparedness and response and to minimize
duplication of effort; and

(C)

in paragraph (3), by inserting before the
period at the end the following: and update such standards as
necessary;

(2)

by striking subsection (c); and

(3)

in subsection (d)—

(A)

in the subsection heading, by striking
Public Health Situational
Awareness and inserting Modernizing Public Health Situational Awareness
and BioSurveillance;

(B)

in paragraph (1)—

(i)

by striking Pandemic and All-Hazards
Preparedness Act and inserting Pandemic and All-Hazards Preparedness Reauthorization Act
of 2012; and

(ii)

by inserting , novel emerging
threats, after disease outbreaks;

(C)

by striking paragraph (2) and inserting the
following:

(2)

Strategy and implementation
plan

Not later than 180 days
after the date of enactment of the Pandemic
and All-Hazards Preparedness Reauthorization Act of 2012, the
Secretary shall submit to the appropriate committees of Congress a coordinated
strategy and an accompanying implementation plan that identifies and
demonstrates the measurable steps the Secretary will carry out to—

(A)

develop, implement, and evaluate the
network described in paragraph (1), utilizing the elements described in
paragraph (3);

(B)

modernize and enhance biosurveillance
activities; and

(C)

improve information sharing, coordination,
and communication among disparate biosurveillance systems supported by the
Department of Health and Human
Services.

;

(D)

in paragraph (3)(D), by inserting
community health centers, health centers after poison
control,;

(E)

in paragraph (5), by striking subparagraph
(A) and inserting the following:

(A)

utilize applicable interoperability
standards as determined by the Secretary, and in consultation with the Office
of the National Coordinator for Health Information Technology, through a joint
public and private sector process;

;
and

(F)

by adding at the end the following:

(6)

Consultation with the National Biodefense
Science Board

In carrying out
this section and consistent with section 319M, the National Biodefense Science
Board shall provide expert advice and guidance, including recommendations,
regarding the measurable steps the Secretary should take to modernize and
enhance biosurveillance activities pursuant to the efforts of the Department of
Health and Human Services to ensure comprehensive, real-time, all-hazards
biosurveillance capabilities. In complying with the preceding sentence, the
National Biodefense Science Board shall—

(A)

identify the steps necessary to achieve a
national biosurveillance system for human health, with international
connectivity, where appropriate, that is predicated on State, regional, and
community level capabilities and creates a networked system to allow for
two-way information flow between and among Federal, State, and local government
public health authorities and clinical health care providers;

(B)

identify any duplicative surveillance
programs under the authority of the Secretary, or changes that are necessary to
existing programs, in order to enhance and modernize such activities, minimize
duplication, strengthen and streamline such activities under the authority of
the Secretary, and achieve real-time and appropriate data that relate to
disease activity, both human and zoonotic; and

(C)

coordinate with applicable existing
advisory committees of the Director of the Centers for Disease Control and
Prevention, including such advisory committees consisting of representatives
from State, local, and tribal public health authorities and appropriate public
and private sector health care entities and academic institutions, in order to
provide guidance on public health surveillance
activities.

;

(4)

in subsection (e)(5), by striking 4
years after the date of enactment of the Pandemic and All-Hazards Preparedness
Act and inserting 3 years after the date of enactment of the
Pandemic and All-Hazards Preparedness
Reauthorization Act of 2012;

(5)

in subsection (g), by striking such
sums as may be necessary in each of fiscal years 2007 through 2011 and
inserting $138,300,000 for each of fiscal years 2013 through
2017; and

(6)

by adding at the end the following:

(h)

Definition

For purposes of this section the term
biosurveillance means the process of gathering near real-time
biological data that relates to human and zoonotic disease activity and threats
to human or animal health, in order to achieve early warning and identification
of such health threats, early detection and prompt ongoing tracking of health
events, and overall situational awareness of disease
activity.

Section 505(b)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended
by striking size of clinical trials intended and all that
follows through . The sponsor or applicant and inserting the
following: “size—

(i)(I)

of clinical trials intended to form the
primary basis of an effectiveness claim; or

(II)

in the case where human efficacy studies
are not ethical or feasible, of animal and any associated clinical trials
which, in combination, are intended to form the primary basis of an
effectiveness claim; or

(ii)

with respect to an application for approval
of a biological product under section 351(k) of the Public Health Service Act,
of any necessary clinical study or studies.

in paragraph (1), by striking
sections 505, 510(k), and 515 of this Act and inserting
any provision of this Act;

(B)

in paragraph (2)(A), by striking
under a provision of law referred to in such paragraph and
inserting under section 505, 510(k), or 515 of this Act or section 351
of the Public Health Service Act; and

(C)

in paragraph (3), by striking a
provision of law referred to in such paragraph and inserting a
section of this Act or the Public Health Service Act referred to in paragraph
(2)(A);

(2)

in subsection (b)—

(A)

in the subsection heading, by striking
Emergency and inserting
Emergency or Threat
Justifying Emergency Authorized Use;

(B)

in paragraph (1)—

(i)

in the matter preceding subparagraph (A),
by striking may declare an emergency and inserting may
make a declaration that the circumstances exist;

(ii)

in subparagraph (A), by striking
specified;

(iii)

in subparagraph (B)—

(I)

by striking specified;
and

(II)

by striking ; or and
inserting a semicolon;

(iv)

by amending subparagraph (C) to read as
follows:

(C)

a determination by the Secretary that there
is a public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect, national
security or the health and security of United States citizens living abroad,
and that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such agent or
agents; or

;
and

(v)

by adding at the end the following:

(D)

the identification of a material threat
pursuant to section 319F–2 of the Public Health Service Act sufficient to
affect national security or the health and security of United States citizens
living
abroad.

;

(C)

in paragraph (2)—

(i)

in subparagraph (A), by amending clause
(ii) to read as follows:

(ii)

a change in the approval status of the
product such that the circumstances described in subsection (a)(2) have ceased
to exist.

;

(ii)

by striking subparagraph (B); and

(iii)

by redesignating subparagraph (C) as
subparagraph (B);

(D)

in paragraph (4), by striking
advance notice of termination, and renewal under this
subsection. and inserting , and advance notice of termination
under this subsection.; and

(E)

by adding at the end the following:

(5)

Explanation by Secretary

If an authorization under this section with
respect to an unapproved product or an unapproved use of an approved product
has been in effect for more than 1 year, the Secretary shall provide in writing
to the sponsor of such product an explanation of the scientific, regulatory, or
other obstacles to approval, licensure, or clearance of such product or use,
including specific actions to be taken by the Secretary and the sponsor to
overcome such
obstacles.

;

(3)

in subsection (c)—

(A)

in the matter preceding paragraph
(1)—

(i)

by inserting the Assistant Secretary
for Preparedness and Response, after consultation
with;

(ii)

by striking Health and and
inserting Health, and; and

(iii)

by striking circumstances of the
emergency involved and inserting applicable circumstances
described in subsection (b)(1);

(B)

in paragraph (1), by striking
specified and inserting referred to; and

(C)

in paragraph (2)(B), by inserting ,
taking into consideration the material threat posed by the agent or agents
identified in a declaration under subsection (b)(1)(D), if applicable
after risks of the product;

(4)

in subsection (d)(3), by inserting ,
to the extent practicable given the circumstances of the emergency,
after including;

(5)

in subsection (e)—

(A)

in paragraph (1)(A), by striking
circumstances of the emergency and inserting applicable
circumstances described in subsection (b)(1);

(B)

in paragraph (1)(B), by amending clause
(iii) to read as follows:

(iii)

Appropriate conditions with respect to
collection and analysis of information concerning the safety and effectiveness
of the product with respect to the use of such product during the period when
the authorization is in effect and a reasonable time following such
period.

;

(C)

in paragraph (2)—

(i)

in subparagraph (A)—

(I)

by striking manufacturer of the
product and inserting person;

(II)

by striking circumstances of the
emergency and inserting applicable circumstances described in
subsection (b)(1); and

(III)

by inserting at the end before the period
or in paragraph (1)(B);

(ii)

in subparagraph (B)(i), by inserting before
the period at the end , except as provided in section 564A with respect
to authorized changes to the product expiration date; and

(iii)

by amending subparagraph (C) to read as
follows:

(C)

In establishing conditions under this
paragraph with respect to the distribution and administration of the product
for the unapproved use, the Secretary shall not impose conditions that would
restrict distribution or administration of the product when distributed or
administered for the approved use.

;
and

(D)

by amending paragraph (3) to read as
follows:

(3)

Good manufacturing practice;
prescription

With respect to
the emergency use of a product for which an authorization under this section is
issued (whether an unapproved product or an unapproved use of an approved
product), the Secretary may waive or limit, to the extent appropriate given the
applicable circumstances described in subsection (b)(1)—

(A)

requirements regarding current good
manufacturing practice otherwise applicable to the manufacture, processing,
packing, or holding of products subject to regulation under this Act, including
such requirements established under section 501 or 520(f)(1), and including
relevant conditions prescribed with respect to the product by an order under
section 520(f)(2);

(B)

requirements established under section
503(b); and

(C)

requirements established under section
520(e).

;

(6)

in subsection (g)—

(A)

in the subsection heading, by inserting
Review
and before Revocation;

(B)

in paragraph (1), by inserting after the
period at the end the following: “As part of such review, the Secretary shall
regularly review the progress made with respect to the approval, licensure, or
clearance of—

(A)

an unapproved product for which an
authorization was issued under this section; or

(B)

an unapproved use of an approved product
for which an authorization was issued under this
section.

;
and

(C)

by amending paragraph (2) to read as
follows:

(2)

Revision and revocation

The Secretary may revise or revoke an
authorization under this section if—

(A)

the circumstances described under
subsection (b)(1) no longer exist;

(B)

the criteria under subsection (c) for
issuance of such authorization are no longer met; or

(C)

other circumstances make such revision or
revocation appropriate to protect the public health or
safety.

;

(7)

in subsection (h)(1), by adding after the
period at the end the following: The Secretary shall make any revisions
to an authorization under this section available on the Internet Web site of
the Food and Drug Administration.;

(8)

by adding at the end of subsection (j) the
following:

(4)

Nothing in this section shall be construed
as authorizing a delay in the review or other consideration by the Secretary of
any application or submission pending before the Food and Drug Administration
for a product for which an authorization under this section is
issued.

;
and

(9)

by adding at the
end the following:

(m)

Categorization
of laboratory tests associated with devices subject to authorization

(1)

In
general

In issuing an authorization under this section with
respect to a device, the Secretary may, subject to the provisions of this
section, determine that a laboratory examination or procedure associated with
such device shall be deemed, for purposes of section 353 of the Public Health
Service Act, to be in a particular category of examinations and procedures
(including the category described by subsection (d)(3) of such section) if,
based on the totality of scientific evidence available to the Secretary—

(A)

such
categorization would be beneficial to protecting the public health; and

(B)

the known and
potential benefits of such categorization under the circumstances of the
authorization outweigh the known and potential risks of the
categorization.

(2)

Conditions of
determination

The Secretary may establish appropriate conditions
on the performance of the examination or procedure pursuant to such
determination.

(3)

Effective
period

A determination under this subsection shall be effective
for purposes of section 353 of the Public Health Service Act notwithstanding
any other provision of that section during the effective period of the relevant
declaration under subsection
(b).

is approved or cleared under this chapter
or licensed under section 351 of the Public Health Service Act;

(B)(i)

is intended for use to prevent, diagnose,
or treat a disease or condition involving a biological, chemical, radiological,
or nuclear agent or agents; or

(ii)

is intended for use to prevent, diagnose,
or treat a serious or life-threatening disease or condition caused by a product
described in clause (i); and

(C)

is intended for use during the
circumstances under which—

(i)

a determination described in subparagraph
(A), (B), or (C) of section 564(b)(1) has been made by the Secretary of
Homeland Security, the Secretary of Defense, or the Secretary, respectively;
or

(ii)

the identification of a material threat
described in subparagraph (D) of section 564(b)(1) has been made pursuant to
section 319F–2 of the Public Health Service Act.

(2)

Product

The term product means a drug,
device, or biological product.

(b)

Expiration
dating

(1)

In
general

The Secretary may extend the expiration date and
authorize the introduction or delivery for introduction into interstate
commerce of an eligible product after the expiration date provided by the
manufacturer if—

(A)

the expiration
date extension is intended to support the United States ability to
protect—

(i)

the public health;
or

(ii)

military
preparedness and effectiveness; and

(B)

the expiration
date extension is supported by an appropriate scientific evaluation that is
conducted or accepted by the Secretary.

(2)

Requirements and
conditions

Any extension of an expiration date under paragraph
(1) shall, as part of the extension, identify—

(A)

each specific lot,
batch, or other unit of the product for which extended expiration is
authorized;

(B)

the duration of
the extension; and

(C)

any other
requirements or conditions as the Secretary may deem appropriate for the
protection of the public health, which may include requirements for, or
conditions on, product sampling, storage, packaging or repackaging, transport,
labeling, notice to product recipients, recordkeeping, periodic testing or
retesting, or product disposition.

(3)

Effect

Notwithstanding
any other provision of this Act or the Public Health Service Act, an eligible
product shall not be considered an unapproved product (as defined in section
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under this Act
because, with respect to such product, the Secretary has, under paragraph (1),
extended the expiration date and authorized the introduction or delivery for
introduction into interstate commerce of such product after the expiration date
provided by the manufacturer.

(4)

Expiration date

For purposes of this subsection, the term
expiration date means the date established through appropriate
stability testing required by the regulations issued by the Secretary to ensure
that the product meets applicable standards of identity, strength, quality, and
purity at the time of use.

(c)

Current good manufacturing
practice

(1)

In general

The Secretary may, when the circumstances
of a domestic, military, or public health emergency or material threat
described in subsection (a)(1)(C) so warrant, authorize, with respect to an
eligible product, deviations from current good manufacturing practice
requirements otherwise applicable to the manufacture, processing, packing, or
holding of products subject to regulation under this Act, including
requirements under section 501 or 520(f)(1) or applicable conditions prescribed
with respect to the eligible product by an order under section
520(f)(2).

(2)

Effect

Notwithstanding any other provision of this
Act or the Public Health Service Act, an eligible product shall not be
considered an unapproved product (as defined in section 564(a)(2)(A)) and shall
not be deemed adulterated or misbranded under this Act because, with respect to
such product, the Secretary has authorized deviations from current good
manufacturing practices under paragraph (1).

(d)

Emergency
dispensing

The requirements of sections 503(b) and 520(e) shall
not apply to an eligible product, and the product shall not be considered an
unapproved product (as defined in section 564(a)(2)(A)) and shall not be deemed
adulterated or misbranded under this Act because it is dispensed without an
individual prescription, if—

(1)

the product is dispensed during the
circumstances described in subsection (a)(1)(C); and

(2)

such dispensing
without an individual prescription occurs—

(A)

as permitted under
the law of the State in which the product is dispensed; or

(B)

in accordance with
an order issued by the Secretary, for the purposes and duration of the
circumstances described in subsection (a)(1)(C).

(e)

Emergency use instructions

(1)

In general

The Secretary, acting through an
appropriate official within the Department of Health and Human Services, may
create and issue emergency use instructions to inform health care providers or
individuals to whom an eligible product is to be administered concerning such
product's approved, licensed, or cleared conditions of use.

(2)

Effect

Notwithstanding any other provisions of
this Act or the Public Health Service Act, a product shall not be considered an
unapproved product and shall not be deemed adulterated or misbranded under this
Act because of the issuance of emergency use instructions under paragraph (1)
with respect to such product or the introduction or delivery for introduction
of such product into interstate commerce accompanied by such
instructions—

(A)

during an emergency response to an actual
emergency that is the basis for a determination described in subsection
(a)(1)(C)(i); or

(B)

by a government entity (including a
Federal, State, local, or tribal government entity), or a person acting on
behalf of such a government entity, in preparation for an emergency
response.

The Secretary may
waive any requirement of this section with respect to a qualified
countermeasure (as defined in section 319F–1(a)(2) of the Public Health Service
Act) to which a requirement under this section has been applied, if the
Secretary determines that such waiver is required to mitigate the effects of,
or reduce the severity of, the circumstances under which—

(1)

a determination described in subparagraph
(A), (B), or (C) of section 564(b)(1) has been made by the Secretary of
Homeland Security, the Secretary of Defense, or the Secretary, respectively;
or

(2)

the identification of a material threat
described in subparagraph (D) of section 564(b)(1) has been made pursuant to
section 319F–2 of the Public Health Service
Act.

.

(d)

Products held for emergency
use

The Federal Food, Drug,
and Cosmetic Act (21
U.S.C. 301 et seq.) is amended by inserting after section 564A,
as added by subsection (b), the following:

564B.

Products held for emergency
use

It is not a violation of
any section of this Act or of the Public Health Service Act for a government
entity (including a Federal, State, local, or tribal government entity), or a
person acting on behalf of such a government entity, to introduce into
interstate commerce a product (as defined in section 564(a)(4)) intended for
emergency use, if that product—

(1)

is intended to be held and not used;
and

(2)

is held and not used, unless and until that
product—

(A)

is approved, cleared, or licensed under
section 505, 510(k), or 515 of this Act or section 351 of the Public Health
Service Act;

(B)

is authorized for investigational use under
section 505 or 520 of this Act or section 351 of the Public Health Service Act;
or

(C)

is authorized for use under section
564.

.

303.

Definitions

Section 565 of the Federal Food, Drug, and
Cosmetic Act (21
U.S.C. 360bbb–4) is amended by striking The Secretary,
in consultation and inserting the following:

(a)

Definitions

In this section—

(1)

the term countermeasure means
a qualified countermeasure, a security countermeasure, and a qualified pandemic
or epidemic product;

(2)

the term qualified
countermeasure has the meaning given such term in section 319F–1 of the
Public Health Service Act;

(3)

the term security
countermeasure has the meaning given such term in section 319F–2 of such
Act; and

(4)

the term qualified pandemic or
epidemic product means a product that meets the definition given such
term in section 319F–3 of the Public Health Service Act and—

(A)

that has been identified by the Department
of Health and Human Services or the Department of Defense as receiving funding
directly related to addressing chemical, biological, radiological, or nuclear
threats, including pandemic influenza; or

(B)

is included under this paragraph pursuant
to a determination by the Secretary.

(b)

General
duties

The Secretary, in
consultation

.

304.

Enhancing medical countermeasure
activities

Section 565 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4), as amended
by section 303, is further amended—

(1)

in the section heading, by striking
Technical
Assistance and inserting Countermeasure Development, Review, and Technical
Assistance;

(2)

in subsection (b), by striking the
subsection enumerator and all that follows through shall
establish and inserting the following:

(b)

General
duties

In order to accelerate
the development, stockpiling, approval, licensure, and clearance of qualified
countermeasures, security countermeasures, and qualified pandemic or epidemic
products, the Secretary, in consultation with the Assistant Secretary for
Preparedness and Response, shall—

(1)

ensure the appropriate involvement of Food
and Drug Administration personnel in interagency activities related to
countermeasure advanced research and development, consistent with sections
319F, 319F–1, 319F–2, 319F–3, 319L, and 2811 of the Public Health Service
Act;

(2)

ensure the appropriate involvement and
consultation of Food and Drug Administration personnel in any flexible
manufacturing activities carried out under section 319L of the Public Health
Service Act, including with respect to meeting regulatory requirements set
forth in this Act;

(3)

promote countermeasure expertise within the
Food and Drug Administration by—

(A)

ensuring that Food and Drug Administration
personnel involved in reviewing countermeasures for approval, licensure, or
clearance are informed by the Assistant Secretary for Preparedness and Response
on the material threat assessment conducted under section 319F–2 of the Public
Health Service Act for the agent or agents for which the countermeasure under
review is intended;

holding public meetings at least twice
annually to encourage the exchange of scientific ideas; and

(D)

establishing protocols to ensure that
countermeasure reviewers have sufficient training or experience with
countermeasures;

(4)

maintain teams, composed of Food and Drug
Administration personnel with expertise on countermeasures, including specific
countermeasures, populations with special clinical needs (including children
and pregnant women that may use countermeasures, as applicable and
appropriate), classes or groups of countermeasures, or other
countermeasure-related technologies and capabilities, that shall—

(A)

consult with countermeasure experts,
including countermeasure sponsors and applicants, to identify and help resolve
scientific issues related to the approval, licensure, or clearance of
countermeasures, through workshops or public meetings; and

(B)

improve and advance the science relating to
the development of new tools, standards, and approaches to assessing and
evaluating countermeasures—

(i)

in order to inform the process for
countermeasure approval, clearance, and licensure; and

(ii)

with respect to the development of
countermeasures for populations with special clinical needs, including children
and pregnant women, in order to meet the needs of such populations, as
necessary and appropriate; and

(5)

establish

;
and

(3)

by adding at the end the following:

(c)

Final Guidance
on development of animal models

(1)

In
general

Not later than 1 year after the date of the enactment of
the Pandemic and All-Hazards Preparedness
Reauthorization Act of 2012, the Secretary shall provide final
guidance to industry regarding the development of animal models to support
approval, clearance, or licensure of countermeasures referred to in subsection
(a) when human efficacy studies are not ethical or feasible.

(2)

Authority to
extend deadline

The Secretary
may extend the deadline for providing final guidance under paragraph (1) by not
more than 6 months upon submission by the Secretary of a report on the status
of such guidance to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor, and Pensions of
the Senate.

(d)

Development and animal modeling
procedures

(1)

Availability of animal model
meetings

To facilitate the
timely development of animal models and support the development, stockpiling,
licensure, approval, and clearance of countermeasures, the Secretary shall, not
later than 180 days after the enactment of this subsection, establish a
procedure by which a sponsor or applicant that is developing a countermeasure
for which human efficacy studies are not ethical or practicable, and that has
an approved investigational new drug application or investigational device
exemption, may request and receive—

(A)

a meeting to discuss proposed animal model
development activities; and

(B)

a meeting prior to initiating pivotal
animal studies.

(2)

Pediatric models

To facilitate the development and selection
of animal models that could translate to pediatric studies, any meeting
conducted under paragraph (1) shall include discussion of animal models for
pediatric populations, as appropriate.

(e)

Review and approval of
countermeasures

(1)

Material threat

When evaluating an application or
submission for approval, licensure, or clearance of a countermeasure, the
Secretary shall take into account the material threat posed by the chemical,
biological, radiological, or nuclear agent or agents identified under section
319F–2 of the Public Health Service Act for which the countermeasure under
review is intended.

(2)

Review expertise

When practicable and appropriate, teams of
Food and Drug Administration personnel reviewing applications or submissions
described under paragraph (1) shall include a reviewer with sufficient training
or experience with countermeasures pursuant to the protocols established under
subsection
(b)(3)(D).

.

305.

Regulatory management plans

Section 565 of the Federal Food, Drug, and
Cosmetic Act (21
U.S.C. 360bbb–4), as amended by section 304, is further amended
by adding at the end the following:

(f)

Regulatory management plan

(1)

Definition

In this subsection, the term eligible
countermeasure means—

(A)

a security countermeasure with respect to
which the Secretary has entered into a procurement contract under section
319F–2(c) of the Public Health Service Act; or

(B)

a countermeasure with respect to which the
Biomedical Advanced Research and Development Authority has provided funding
under section 319L of the Public Health Service Act for advanced research and
development.

(2)

Regulatory management plan
process

The Secretary, in
consultation with the Assistant Secretary for Preparedness and Response and the
Director of the Biomedical Advanced Research and Development Authority, shall
establish a formal process for obtaining scientific feedback and interactions
regarding the development and regulatory review of eligible countermeasures by
facilitating the development of written regulatory management plans in
accordance with this subsection.

(3)

Submission of request and proposed plan by
sponsor or applicant

(A)

In general

A sponsor or applicant of an eligible
countermeasure may initiate the process described under paragraph (2) upon
submission of a written request to the Secretary. Such request shall include a
proposed regulatory management plan.

(B)

Timing of submission

A sponsor or applicant may submit a written
request under subparagraph (A) after the eligible countermeasure has an
investigational new drug or investigational device exemption in effect.

(C)

Response by Secretary

The Secretary shall direct the Food and
Drug Administration, upon submission of a written request by a sponsor or
applicant under subparagraph (A), to work with the sponsor or applicant to
agree on a regulatory management plan within a reasonable time not to exceed 90
days. If the Secretary determines that no plan can be agreed upon, the
Secretary shall provide to the sponsor or applicant, in writing, the scientific
or regulatory rationale why such agreement cannot be reached.

(4)

Plan

The content of a regulatory management plan
agreed to by the Secretary and a sponsor or applicant shall include—

(A)

an agreement between the Secretary and the
sponsor or applicant regarding developmental milestones that will trigger
responses by the Secretary as described in subparagraph (B);

(B)

performance targets and goals for timely
and appropriate responses by the Secretary to the triggers described under
subparagraph (A), including meetings between the Secretary and the sponsor or
applicant, written feedback, decisions by the Secretary, and other activities
carried out as part of the development and review process; and

(C)

an agreement on how the plan shall be
modified, if needed.

(5)

Milestones and performance
targets

The developmental
milestones described in paragraph (4)(A) and the performance targets and goals
described in paragraph (4)(B) shall include—

(A)

feedback from the Secretary regarding the
data required to support the approval, clearance, or licensure of the eligible
countermeasure involved;

(B)

feedback from the Secretary regarding the
data necessary to inform any authorization under section 564;

(C)

feedback from the Secretary regarding the
data necessary to support the positioning and delivery of the eligible
countermeasure, including to the Strategic National Stockpile;

(D)

feedback from the Secretary regarding the
data necessary to support the submission of protocols for review under section
505(b)(5)(B);

(E)

feedback from the Secretary regarding any
gaps in scientific knowledge that will need resolution prior to approval,
licensure, or clearance of the eligible countermeasure and plans for conducting
the necessary scientific research;

(F)

identification of the population for which
the countermeasure sponsor or applicant seeks approval, licensure, or clearance
and the population for which desired labeling would not be appropriate, if
known; and

(G)

as necessary and appropriate, and to the
extent practicable, a plan for demonstrating safety and effectiveness in
pediatric populations, and for developing pediatric dosing, formulation, and
administration with respect to the eligible countermeasure, provided that such
plan would not delay authorization under section 564, approval, licensure, or
clearance for adults.

(6)

Prioritization

(A)

Plans for
security countermeasures

The Secretary shall establish regulatory
management plans for all security countermeasures for which a request is
submitted under paragraph (3)(A).

(B)

Plans for other
eligible countermeasures

The Secretary shall determine whether
resources are available to establish regulatory management plans for eligible
countermeasures that are not security countermeasures. If resources are
available to establish regulatory management plans for eligible countermeasures
that are not security countermeasures, and if resources are not available to
establish regulatory management plans for all eligible countermeasures for
which requests have been submitted, the Director of the Biomedical Advanced
Research and Development Authority, in consultation with the Commissioner,
shall prioritize which eligible countermeasures may receive regulatory
management
plans.

.

306.

Report

Section 565 of the Federal Food, Drug, and
Cosmetic Act (21
U.S.C. 360bbb–4), as amended by section 305, is further amended
by adding at the end the following:

(g)

Annual report

Not later than 180 days after the date of
enactment of this subsection, and annually thereafter, the Secretary shall make
publicly available on the Web site of the Food and Drug Administration a report
that details the countermeasure development and review activities of the Food
and Drug Administration, including—

(1)

with respect to the development of new
tools, standards, and approaches to assess and evaluate countermeasures—

(A)

the identification of the priorities of the
Food and Drug Administration and the progress made on such priorities;
and

(B)

the identification of scientific gaps that
impede the development, approval, licensure, or clearance of countermeasures
for populations with special clinical needs, including children and pregnant
women, and the progress made on resolving these challenges;

(2)

with respect to countermeasures for which a
regulatory management plan has been agreed upon under subsection (f), the
extent to which the performance targets and goals set forth in subsection
(f)(4)(B) and the regulatory management plan have been met, including, for each
such countermeasure—

(A)

whether the regulatory management plan was
completed within the required timeframe, and the length of time taken to
complete such plan;

(B)

whether the Secretary adhered to the timely
and appropriate response times set forth in such plan; and

(C)

explanations for any failure to meet such
performance targets and goals;

(3)

the number of regulatory teams established
pursuant to subsection (b)(4), the number of products, classes of products, or
technologies assigned to each such team, and the number of, type of, and any
progress made as a result of consultations carried out under subsection
(b)(4)(A);

(4)

an estimate of resources obligated to
countermeasure development and regulatory assessment, including—

(A)

Center-specific
objectives and accomplishments; and

(B)

the number of
full-time equivalent employees of the Food and Drug Administration who directly
support the review of countermeasures;

(5)

the number of countermeasure applications
and submissions submitted, the number of countermeasures approved, licensed, or
cleared, the status of remaining submitted applications and submissions, and
the number of each type of authorization issued pursuant to section 564;

(6)

the number of written requests for a
regulatory management plan submitted under subsection (f)(3)(A), the number of
regulatory management plans developed, and the number of such plans developed
for security countermeasures; and

(7)

the number, type,
and frequency of meetings between the Food and Drug Administration and—

(A)

sponsors of a
countermeasure as defined in subsection (a); or

(B)

another agency engaged in development or
management of portfolios for such countermeasures, including the Centers for
Disease Control and Prevention, the Biomedical Advanced Research and
Development Authority, the National Institutes of Health, and the appropriate
agencies of the Department of
Defense.

With respect to a drug that is a qualified
countermeasure (as defined in section 319F–1 of the Public Health Service Act),
a security countermeasure (as defined in section 319F–2 of the Public Health
Service Act), or a qualified pandemic or epidemic product (as defined in
section 319F–3 of the Public Health Service Act), the Secretary shall solicit
input from the Assistant Secretary for Preparedness and Response regarding the
need for and, from the Director of the Biomedical Advanced Research and
Development Authority regarding the conduct of, pediatric studies under this
section.

;
and

(2)

in subsection (n)(1), by adding at the end
the following:

(C)

For a drug that is a qualified
countermeasure (as defined in section 319F–1 of the Public Health Service Act),
a security countermeasure (as defined in section 319F–2 of the Public Health
Service Act), or a qualified pandemic or epidemic product (as defined in
section 319F–3 of such Act), in addition to any action with respect to such
drug under subparagraph (A) or (B), the Secretary shall notify the Assistant
Secretary for Preparedness and Response and the Director of the Biomedical
Advanced Research and Development Authority of all pediatric studies in the
written request issued by the Commissioner of Food and
Drugs.

.

(b)

Addition to priority list
considerations

Section 409I
of the Public Health Service Act (42 U.S.C. 284m) is amended—

(1)

by striking subsection (a)(2) and inserting
the following:

(2)

Consideration of available
information

In developing and
prioritizing the list under paragraph (1), the Secretary—

(A)

shall consider—

(i)

therapeutic gaps in pediatrics that may
include developmental pharmacology, pharmacogenetic determinants of drug
response, metabolism of drugs and biologics in children, and pediatric clinical
trials;

(ii)

particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of therapeutics, including
drugs and biologics, may be beneficial in pediatric populations; and

(iii)

the adequacy of necessary infrastructure to
conduct pediatric pharmacological research, including research networks and
trained pediatric investigators; and

(B)

may consider the availability of qualified
countermeasures (as defined in section 319F–1), security countermeasures (as
defined in section 319F–2), and qualified pandemic or epidemic products (as
defined in section 319F–3) to address the needs of pediatric populations, in
consultation with the Assistant Secretary for Preparedness and Response,
consistent with the purposes of this
section.

; and

(2)

in subsection (b), by striking
subsection (a) and inserting paragraphs (1) and (2)(A) of
subsection (a).

(c)

Advice and recommendations of the pediatric
advisory committee regarding countermeasures for pediatric
populations

Subsection (b)(2)
of section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m
note) is amended—

(1)

in subparagraph (C), by striking the period
and inserting ; and; and

(2)

by adding at the end the following:

(D)

the development of countermeasures (as
defined in section 565(a) of the Federal Food, Drug, and Cosmetic Act) for
pediatric
populations.

.

IV

Accelerating
medical countermeasure advanced research and development

401.

BioShield

(a)

Procurement of
countermeasures

Section
319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) is
amended—

(1)

in paragraph (1)(B)(i)(III)(bb), by
striking eight years and inserting 10
years;

(2)

in paragraph
(2)(C), by striking the designated congressional committees (as defined
in paragraph (10)) and inserting the appropriate committees of
Congress;

(3)

in paragraph (5)(B)(ii), by striking
eight years and inserting 10 years;

(4)

in subparagraph
(C) of paragraph (6)—

(A)

in the
subparagraph heading, by striking designated congressional committees and
inserting appropriate
congressional committees; and

(B)

by striking
the designated congressional committees and inserting the
appropriate congressional committees; and

(5)

in paragraph (7)(C)—

(A)

in clause (i)(I), by inserting
including advanced research and development, after as may
reasonably be required,;

(B)

in clause (ii)—

(i)

in subclause (III), by striking
eight years and inserting 10 years; and

(ii)

by striking subclause (IX) and inserting
the following:

(IX)

Contract
terms

The Secretary, in any
contract for procurement under this section—

(aa)

may specify—

(AA)

the dosing and administration requirements
for the countermeasure to be developed and procured;

(BB)

the amount of funding that will be
dedicated by the Secretary for advanced research, development, and procurement
of the countermeasure; and

(CC)

the specifications the countermeasure must
meet to qualify for procurement under a contract under this section; and

(bb)

shall provide a clear statement of defined
Government purpose limited to uses related to a security countermeasure, as
defined in paragraph (1)(B).

;
and

(C)

by adding at the end the following:

(viii)

Flexibility

In carrying out this section, the Secretary
may, consistent with the applicable provisions of this section, enter into
contracts and other agreements that are in the best interest of the Government
in meeting identified security countermeasure needs, including with respect to
reimbursement of the cost of advanced research and development as a reasonable,
allowable, and allocable direct cost of the contract
involved.

.

(b)

Reauthorization
of the special reserve fund

Section 319F–2 of the Public Health
Service Act (42
U.S.C. 247d–6b) is amended—

(1)

in subsection
(c)—

(A)

by striking
special reserve fund under paragraph (10) each place it appears
and inserting special reserve fund as defined in subsection (h);
and

(B)

by striking
paragraphs (9) and (10); and

(2)

by adding at the
end the following:

(g)

Special reserve
fund

(1)

Authorization of
appropriations

In addition to
amounts appropriated to the special reserve fund prior to the date of the
enactment of this subsection, there is authorized to be appropriated, for the
procurement of security countermeasures under subsection (c) and for carrying
out section 319L (relating to the Biomedical Advanced Research and Development
Authority), $2,800,000,000 for the period of fiscal years 2014 through 2018.
Amounts appropriated pursuant to the preceding sentence are authorized to
remain available until September 30, 2019.

(2)

Use of special
reserve fund for advanced research and development

The
Secretary may utilize not more than 50 percent of the amounts authorized to be
appropriated under paragraph (1) to carry out section 319L (related to the
Biomedical Advanced Research and Development Authority). Amounts authorized to
be appropriated under this subsection to carry out section 319L are in addition
to amounts otherwise authorized to be appropriated to carry out such
section.

(3)

Restrictions on
use of funds

Amounts in the special reserve fund shall not be
used to pay costs other than payments made by the Secretary to a vendor for
advanced development (under section 319L) or for procurement of a security
countermeasure under subsection (c)(7).

(4)

Report

Not later than 30 days after any date on
which the Secretary determines that the amount of funds in the special reserve
fund available for procurement is less than $1,500,000,000, the Secretary shall
submit to the appropriate committees of Congress a report detailing the amount
of such funds available for procurement and the impact such reduction in
funding will have—

(A)

in meeting the security countermeasure
needs identified under this section; and

The term advanced research and
development has the meaning given such term in section 319L(a).

(2)

The term
special reserve fund means the Biodefense
Countermeasures appropriations account, any appropriation made available
pursuant to section 521(a) of the Homeland Security Act of 2002, and any
appropriation made available pursuant to subsection
(g)(1).

.

402.

Biomedical Advanced Research and
Development Authority

(a)

Duties

Section 319L(c)(4) of the Public Health
Service Act (42 U.S.C. 247d–7e(c)(4)) is amended—

(1)

in subparagraph (B)(iii), by inserting
(which may include advanced research and development for purposes of
fulfilling requirements under the Federal Food, Drug, and Cosmetic Act or
section 351 of this Act) after development; and

Section 319L(c)(5) of the Public Health
Service Act (42 U.S.C. 247d–7e(c)(5)) is amended by adding at the end the
following:

(G)

Government purpose

In awarding contracts, grants, and
cooperative agreements under this section, the Secretary shall provide a clear
statement of defined Government purpose related to activities included in
subsection (a)(6)(B) for a qualified countermeasure or qualified pandemic or
epidemic
product.

.

(c)

Fund

Paragraph (2) of section 319L(d) of the
Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is amended to read as
follows:

(2)

Funding

To carry out the purposes of this section,
there is authorized to be appropriated to the Fund $415,000,000 for each of
fiscal years 2013 through 2017, such amounts to remain available until
expended.

.

(d)

Continued Inapplicability of Certain
Provisions

Section
319L(e)(1)(C) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is
amended by striking 7 years and inserting 11
years.

Section 319L of the Public Health Service
Act (42 U.S.C.
247d–7e) is amended by adding at the end the following:

(f)

Independent evaluation

(1)

In general

Not later than 180 days after the date of
enactment of this subsection, the Comptroller General of the United States
shall conduct an independent evaluation of the activities carried out to
facilitate flexible manufacturing capacity pursuant to this section.

(2)

Report

Not later than 1 year after the date of
enactment of this subsection, the Comptroller General of the United States
shall submit to the appropriate committees of Congress a report concerning the
results of the evaluation conducted under paragraph (1). Such report shall
review and assess—

(A)

the extent to which flexible manufacturing
capacity under this section is dedicated to chemical, biological, radiological,
and nuclear threats;

(B)

the activities supported by flexible
manufacturing initiatives; and

(C)

the ability of flexible manufacturing
activities carried out under this section to—

(i)

secure and leverage leading technical
expertise with respect to countermeasure advanced research, development, and
manufacturing processes; and

Section 319F–1(a)(2)(A) of the Public
Health Service Act (42 U.S.C. 247d–6a(a)(2)(A)) is amended—

(A)

in the matter preceding clause (i), by
striking to— and inserting —;

(B)

in clause (i)—

(i)

by striking diagnose and
inserting to diagnose; and

(ii)

by striking ; or and
inserting a semicolon;

(C)

in clause (ii)—

(i)

by striking diagnose and
inserting to diagnose; and

(ii)

by striking the period at the end and
inserting ; or; and

(D)

by adding at the end the following:

(iii)

is a product or technology intended to
enhance the use or effect of a drug, biological product, or device described in
clause (i) or
(ii).

.

(2)

Qualified pandemic or epidemic
product

Section
319F–3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(7)(A))
is amended—

(A)

in clause (i)(II), by striking ;
or and inserting ;;

(B)

in clause (ii), by striking ;
and and inserting ; or; and

(C)

by adding at the end the following:

(iii)

a product or technology intended to enhance
the use or effect of a drug, biological product, or device described in clause
(i) or (ii);
and

.

(3)

Technical amendments

Section 319F–3(i) of the Public Health
Service Act (42 U.S.C. 247d–6d(i)) is amended—

(A)

in paragraph (1)(C), by inserting ,
564A, or 564B after 564; and

(B)

in paragraph (7)(B)(iii), by inserting
, 564A, or 564B after 564.

403.

Strategic National Stockpile

Section 319F–2 of the Public Health Service
Act (42 U.S.C.
247d–6b) is amended—

(1)

in subsection (a)—

(A)

in paragraph (1)—

(i)

by inserting consistent with section
2811 before by the Secretary to be appropriate;
and

(ii)

by inserting before the period at the end
of the second sentence the following: and shall submit such review
annually to the appropriate congressional committees of jurisdiction to the
extent that disclosure of such information does not compromise national
security; and

(B)

in paragraph (2)(D), by inserting before
the semicolon at the end the following: and that the potential depletion
of countermeasures currently in the stockpile is identified and appropriately
addressed, including through necessary replenishment; and

(2)

in subsection (f)(1), by striking
$640,000,000 for fiscal year 2002, and such sums as may be necessary for
each of fiscal years 2003 through 2006. Such authorization is in addition to
amounts in the special reserve fund referred to in subsection
(c)(10)(A). and inserting $533,800,000 for each of fiscal years
2013 through 2017. Such authorization is in addition to amounts in the special
reserve fund referred to in subsection (h)..

404.

National Biodefense Science
Board

Section 319M(a) of the
Public Health Service Act (42 U.S.C. 247d–f(a)) is amended—

(1)

in paragraph (2)—

(A)

in subparagraph (D)—

(i)

in clause (i), by striking
and at the end;

(ii)

in clause (ii), by striking the period and
inserting a semicolon; and

(iii)

by adding at the end the following:

(iii)

one such member shall be an individual with
pediatric subject matter expertise; and

(iv)

one such member shall be a State, tribal,
territorial, or local public health
official.

;
and

(B)

by adding at the end the following flush
sentence:

Nothing in this paragraph
shall preclude a member of the Board from satisfying two or more of the
requirements described in subparagraph (D).; and(2)

in paragraph (5)—

(A)

in subparagraph (B), by striking
and at the end;

(B)

in subparagraph (C), by striking the period
and inserting ; and; and

(C)

by adding at the end the following:

(D)

provide any recommendation, finding, or
report provided to the Secretary under this paragraph to the appropriate
committees of
Congress.